April 17, 2012, Billerica, MA — EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today introduced Strat-M™ membrane for screening compounds and formulations via in vitro diffusion studies. The synthetic membrane can be successfully used in place of human or animal skin to provide meaningful and reproducible information about permeation characteristics of the compound through human skin.
Strat-M™ membrane is a synthetic membrane constructed of multiple layers of polyethersulfone polymer creating morphology similar to human skin; membrane layers are increasingly more porous and thick through the depth of the membrane. After casting, the membrane undergoes a post treatment to impart lipophilic characteristics similar to human skin.
During development of transdermal drugs and personal care products, assessment of percutaneous adsorption and diffusion of the active ingredients is typically conducted using human cadaver skin or animal skin models (rat, mouse, pig). Unfortunately, a number of drawbacks to these biological models exist – the most significant being high variability. The diffusion rate through human cadaver skin is dependent on the site from which the skin is removed and affected by the age, race, and sex of the donor. Plus, biological models have special storage requirements, may be difficult to procure, and are considered biohazard and need special disposal.
“Results from our internal studies indicate that diffusion through the Strat-M™ membrane is predictive of diffusion through human skin for a wide range of compounds and formulations,” notes John Sweeney, Head of Life Science Business Field, EMD Millipore. In most cases, the correlation between Strat-M™ membrane and human skin is much better than the commonly used animal skin models for in in vitro testing of transdermal formulations. Furthermore, the benefits of a synthetic test model with low variability simplify experimental design and data analysis.
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About EMD Millipore
EMD Millipore is the Life Science division of Merck KGaA, Darmstadt, Germany, offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.
Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2011 revenues of EUR 2.4 billion.